STATEMENT OF WORK (SOW) CONSIGNMENT AGREEMENT DEPUY SYNTHES MITEK Upon entry at the Detroit VAMC, all Contractors, Reps, and visitors are required to check into this facility via the Vendor Clock-In stations. They are conveniently located at the Canfield Street entrance for patients and visitors and near the Emergency Room. Scope: The contractor shall provide all supplies in the stated quantities as referenced on the consignment agreement inventory list. The inventory will be in the designated Surgery Supply Storage Room C4666. It is expected that the initial inventory will be available by April 1, 2023, or no later than (10) calendar days after receipt of the fully executed Agreement. Detroit VA will provide adequate space/shelving for stocking the products. The contractor will provide a complete listing of model and part numbers to the Contracting Officer Representative upon delivery of the initial inventory. The frequency of Contractor s visit should be at least 1x per quarter. Technical Requirements: This initial consignment is the startup of all replenishment/replacement services for Anchors and Sutures with Cords such as (MINI QA+ #2/O OCORD V-5 MINI QA+ #2/O OCORD V-5, MICRO QA+ #3/0 OC V4 MICRO QA+ #3/0 OC V4, 4.5 HELIX ADVANCE BR W/OCORD, 4.5 HELIX ADVANCE BR3SUT W/OC, 4.75 HELIX ADVANCE KNTLS BR, and 5.5 HEALIX ADVANCE KNTLS BR). If it is discovered that the stock quantities fall below the agreed minimum stock level, the Contractor must replenish the stock level with like quantities of items within 48 hours at no additional expense to the Government. The Designated Contractor Representative Officer (COR) assigned to this facility will periodically (no less than once per month) conduct a physical inventory of the consignment items and the results shall be detailed in a report. The Contractor shall include usage, par level, recalls, outdated/replaced items and removed items. A copy of the report shall be given to the COR. Par Levels can be changed at any time during the effective period of this agreement. The government reserves the right of additions and deletions on the contract and such actions MUST be coordinated with the COR who must follow up with the Contracting Officer (CO) with written confirmation within 24 hours. All unused/excess, defective and expired IOLs are the direct responsibility of the Contractor, including removal/disposal and incurred expenses (unless Detroit VA has misused or lost the product). Period of Performance: Monitoring is to begin April 1, 2023, through March 31, 2024 Upon expiration/termination of the agreement, VHA will reconcile all consignment stock units. The contractor will remove all unused items at the end of the effective period of the agreement without reimbursement or other expense to the Government. The Government assumes no liability for any item(s) assigned to VHA on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by VHA staff. The Contractor Representative will maintain routine communication with Surgery s COR regarding any related details to this consignment. Description of Inventory Items: Notice of Intent to Sole Source Requirement: The Department of Veterans Affairs, VA Healthcare System, Network Contracting Office (NCO) 10 intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1(b), Only One Responsible Source for the following items listed below. The associated NAICS code for this is 339113. The sole source contract will be awarded to: Johnson & Johnson Healthcare Systems, Inc., 425 Hoes Lane, Piscataway, New Jersey 08855, United States. A firm fixed price contract with four (4) option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 12:00PM EST, Monday, March 27, 2023. VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 553-23-2-103-0667, CONSIGNMENT, DEPUY SYNTHES MITEK 1. Contracting Activity: Department of Veterans Affairs, VISN 10 DETROIT VA Medical Center 2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The estimated annual amount for this consignment is $28,320.00. This is an exclusive request for a consignment agreement for an assortment of sizes and models of anchors and sutures with cords, for surgery s plastic and orthopedics services. They will be located in room C4609. 3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: These anchors and sutures with cords are manufactured and distributed by Depuy Synthes Mitek only. The exact sizes/models aren t always known and/or available during surgical procedures. Their availability at any given moment during a procedure would greatly reduce the likelihood of unhealthy/warranted situations upon demand. 4. Description of market research conducted and results or statement why it was not conducted: Confirmation with OEM, Depuy Synthes Mitek, requested items are not on contract and a consignment is not available through other vendors for these implant items. 5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. __________________________ LouAnn Gilliiland Contracting Officer